Events

Retiro De Equipo (Recall) de Device Recall Padgett Dermatome power supply units

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Integra LifeSciences Corp..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58333
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2225-2011
  • Fecha de inicio del evento
    2011-03-11
  • Fecha de publicación del evento
    2011-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99003
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Dermatone - Product Code GFD
  • Causa
    Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient.
  • Acción
    Integra LifeSciences Corp. initiated their recall by contacting their Sales Representatives via telephone conference calls on 3/10/2011. Separate written recall communications, in the form of an 'URGENT PRODUCT RECALL NOTIFICATION' were provided via E-mail and FedEx to the firm's Sales Representatives on 3/11/2011; and to their hospital and distributor customers on 3/11/2011; 3/14/2011; and on 4/12/2011. The recall notification addressed to the non-Integra Sales Rep customers informs the customers of the problem with the power supply units (that they may not meet the required medical device electrical safety standards which may result in an increased potential for electrical shock). The notification goes on to ask that the customers examine their inventories and determine if they have any affected product on-hand; if so, the customers are instructed to discontinue use of the power supply unit and return the unit(s) to Integra LifeSciences Corporation immediately for reworking. The letter also provides photographs of the affected units which the customer can use to locate and verify the serial number(s) of the device (if applicable). In addition, the notification is accompanied by a 'RECALL ACKNOWLEDGMENT AND RETURN FORM' which the customer is asked to sign and complete in order to document receipt of the recall notification and whether or not the customer has any of the recalled power supply units available for return. The notification letter provided to the Integra Sales Representatives describes the device models affected; the reason for the recall; and asks that the Reps. examine their inventories for the presence of any of the affected power supply units. If found, the Reps are instructed not to use, or to further distribute any of the affected units in their possession, but to immediately make arrangements to return the unit(s) to Integra for rework. The notification supplied to the Sales Reps provides them with a synopsis of the firm's field action

Device

Device Recall Padgett Dermatome power supply units
  • Modelo / Serial
    Univ ersal Power Supply, Part Number DP0007 and DP0800 , used in the Integra Padgett Dermatome, Model S, Part Numbers 3539-700; and the Integra Padgett Dermatome, Model SB, Part Number 3539-800; and the Integra Padgett Dermatome, Model S6, Part Number: 3539-900.   The serial numbers for the affected units are as follows: *S-11, S-137, S-152, S-173, S-186, S-214, S-231, S-243, S-245, S-254, S36, S-233, S-234, S-235, S917P, S-237, S-238, S-239, S444, S-242, S-244, S415, S-247, S-248, S-249, S-250, S-251, S353P, S-253, S-255, S-256, S-257,S-258, S-259, S-260,  S-261, S-262, S-263, S-264, S-265, S-267, S-268, S-269, S-271, S-272, S-273, S-274, S-960, S-961, S-RP-220, S-RP-140, S-RP-182, S-RP-183, S759, S767, S315P, S659, S691, S697, S703,S704, S716, S728, S739, S342P, S412, SB004, SB008, SB021, SB031, SB042, SB043, SB044, SB045, SB050, SB051, SB052, SB073, SB074, SB075, SB076, SB082, SB083, SB088, SB089, SB090, SB091, SB092, SB093, SB094, SB095, SB100, SB102, SB103, SB104, SB107, SB108, SB109, SB111, SB112, SB113, SB114, SB115, SB116, SB117, SB126,SB127, SB130, SB131, SB132, SB133, SB134, SB135, SB136, SB137, SB138, SB139, SB140, SB141, SB142,SB143, SB144, SB145, SB146, SB147, SB148, SB149, SB168, SB169, SB170, SB171, SB172, SB173, SB176,SB177, SB178, SB179, SB180, SB185, SB190, SB192, SB193, SB194, SB195, SB196, SB197, SB198, SB199, SB200, SB204, SB206, SB208, SB210, SB211, SB216, SB221, SB222, SB229, SB231, SB232, SB233, SB237, SB241, SB242, SB243, SB244, SB254, SB256, SB257, SB258, SB259, SB260, SB261, SB262, SB263, SB264, SB265, SB266, SB267, SB268, SB269, SB270, SB271, SB272, SB273, SB274, SB275, SB276, SB291, SB304P, SB327, SB337, SB44, S857, S288, S436, S3856, S3886, S626, SRP220, S714, S715P, SB153, SB154, SB155, SB156, S612, S619, S620, S625, S684, N/A, N/A, SRP223(a), S496, S497, S509, S683, N/A, N/A, S341, S595, S610, S613, S618, S635, S637, S638, S680, S862, S865, S780, S764, S770, S773, S774, S916, S511P, S707,S782, S811, S358, S359, S3866, S456, S428, S520, S430, S431, S432, S529, S455, N/A, N/A, S506, S508, S686, S849, S927, SB249, SB250, SB251, SB252, SB253, SB255, S438, S439, S440, S481, S482, S484, S485, S486, S487, S542P, S596, S694, S696, S634, S495(a), S699, S718, S744, S745, S747, S519, S-538, S818, 5871, S291,S292, SRP228, S644, S645, S650, SB175, S391, S463, S453, S310, S348, S355, S368, S369, S370, S371, S372, S373, S374, S381, S382, S383, S384, S530, S654, SB006, SB038, SB105, SB125, SB128, SB129, SB150, SB151,SB152, SB157, SB158, SB159, SB160, SB161, SB162, SB163, SB164, SB165, SB166, SB167, SB174, SB181,SB182, SB183, SB184, SB186, SB187, SB188, SB189, SB191, SB201, SB202, SB203, SB205, SB207, SB223,SB224, SB227, SB228, SB278, SB279, SB280, SB281, SB286, SB297, SB331, SB332, SB88, SB039, S469, SB005, SB010, S679, S604, S760, S776, S594, S771, S473, S772, S785, S449, S435, S551, S817, S814, S779 S710, S719, S724, S727, S419, S709, 1/1/1989, N/A, N/A, SB123, S611, 1-582, S523, S524, S526, S527, S531, S532, S533, S582, S614, S295, S296, S362, S363, S577, S677, S387, S777, S778, S3936, S416, S417, S418, S390, S521, S539, S548, S583, S655, S669, S673, S495(b), S733, S546, S477, S514, S516, S517, S333, S681, S781,S839, S706, S424, S446, S660, S726, S361, S545, S682, S700, S717, SRP185, S330, S437, N/A, N/A, N/A, N/A, S276, S277, S278, S279, S280, S281, S282, S283, S284, S286, S287, S289, S290, S297, S298, S299, S305, S307,S308, S344, S345, S346, S347, S395, S396, S397, S398, S399, S400, S401, S402, S403, S404, S405, S406, S407,S408, S409, S410, S411, S420, S421, S422, SB016, SB017, SB018, SB023, SB024, SB025, SB026, SB027, SB028, SB032, SB033, SB034, SB035, SB036, SB037, SB040, SB041, SB046, SB047, SB049, SB053, SB054, SB055,SB056, SB057, SB058, SB059, SB060, SB061, SB062, SB063, SB064, SB066, SB067, SB068, SB069, SB071,SB072, SB077, SB078, SB079, SB080, SB081, SB084, SB085, SB086, SB087, SB106LC, SB118, SB119, SB120, SB121, SB122, SRP172, SRP173, SB289, SB290, SB324, SB328, SB329, SB330, SB2PC, SB007P, S312P, S736, S749, S752, S597, S598, S599, S4206, S816, S350, S351, S356, S357, S3816, S3876, S665, S675, S851, SRP229,S551, S605, S929, S608, S609, S648, S688, N/A, N/A, N/A, N/A, N/A, N/A, S450, S758, S906, S554, S678, S559, S713, S603, N/A, N/A, N/A, N/A, S513, S788, S789, S306, S4006P, N/A, N/A, SRP211, S322, S323, S457, S458, S319P, S300, S850, S689, S560, S561, S563, S568, S570, S572, S343, S429, S580, S337, S3966, S4016, S4056P,S666PZ, SB282, SB283, SB284, SB285, SB287, SB288, S507, SB065, SB070, SB097, SB098, S366, S367, SB013,SB015, S565, SRP222, S4196, S812, 5587, 5588, 5589, S587, S589, N/A, N/A, S914, S492, S685, S493, S364,S365P, SB012, SB014, SB225, SB226, SB230, SB240, SB277, S502, N/A, N/A, S540, S541, S692, S693, S695, S555, S556, S649, S768, S783, SRP184, SRP186, S483, S720, S543, S544, S336, S360, S905, S314P, S317P,S3836, S3846P, S392, S393, S394P, S4036P, S413, S414, S479, S490, S491, S501, S510, S549, S746P, S748P,SB099, SB101, SB234P, SB235P, SB236, SB245P, SB246, SB247, SB248, SRP243, S459, S3976, S601, S602,S454, S331, SRP242, S926, S925, S633, S629, S550, S488, S489, N/A, N/A, S896, S895, S890, S302, S301, N/A, N/A, SRP231, S293, S923, S349, S750, S442, S441, SRP244, S607, S443, S586, 5586, S309, S584, S576, S471, S910, S687, S536, SRP233, SRP232, S3826, S385, S294P, S784, S753, S751, S722, S721, S711, S708, S705, S698,S579, S578, S575, S574, S573, S567, S558, S557, S329, S328, S327, S326, S325, S324, S389, S690, S663, S661, S335, S334, S332, SB239P, SB238, S730P, S729P, S725, S285, SB124, SB110, S647, S464, S448, S434, S909,S853, S847, S731, S475, S474, S472, S4136, SRP227, SRP221, S339, S466, S908, SRP188, SRP187, SB326, SB325, SB323, SB296, SB295, SB294P, SB293, SB292, SB220, SB219, SB218, SB217, SB215, SB214, SB213, SB212, SB209, S476, S468, S467, S4026P, S3916P, S3906L, S503, S754, S848, S641, S636, SRP201, SRP200, SRP199, SRP198, SRP197, SRP196, SRP195, SRP194, S623, S621, SRP230, S674, S667, S547, S919, S918, S632, S631, S630, S628, S737, S622, S352, S3986, S3926, SRP223(c), N/A, N/A, S735, S593, S592, S591, S590, S581, S500, S499P, S740, S852, S734, S732, and S892. *All Dermatome Power Supply units distributed from 3/2/2005 through 4/19/2010 are subject to recall/replacement. According to the firm, cerain of the suspect units distributed had no identifiable serial numbers but recall letters were sent to the customers of these units. The firm chose to identify these units as: N/A for the sake of counting the serial numbers of the affected product.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including FL, CO, IL, AR, MD, IN, CA, MT, AZ, NY, LA, TX, MA, MO, CT, MI, NE, OH, NC, WV, VA, PA, NJ, TN, UT, MN, OK, WI, GA, AL, WA, KS, OR, AK, DC, SC, NE, MS, RI, NV, IA, and ND and the country of Canada
  • Descripción del producto
    Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. || The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical facilities, where the patient will be under the supervision of trained personnel. The Model SB dermatomes are used in skin banks for the harvesting of cadaver tissues.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.